Description of Event or Problem · 1
PICIS CLINICAL SOLUTIONS RECEIVED AN ENHANCEMENT REQUEST ON (B)(6)-2015: (B)(6) HOSPITAL (OCH) - CAN THE ACCESS TO DOCUMENT WEIGHT IN POUNDS BE COMPLETELY REMOVED FROM THE ER RECORD? OCH IS REPORTING 3 NEAR MISSES WITHIN THE LAST WEEK WITH INFANT WEIGHTS BEING RECORDED IN POUNDS INSTEAD OF KILOS. ENSURING THAT WEIGHT IS RECORDED CORRECTLY IS A PATIENT SAFETY ISSUE AS WEIGHT IS USED TO CALCULATE MEDICATION DOSAGES" FURTHER INVESTIGATION DETERMINED THAT THERE WERE NO REPORTED PATIENT INCIDENTS RELATED TO THE ENHANCEMENT REQUEST. THE ED PULSECHECK PRODUCT CURRENTLY HAS TWO TEMPLATE FIELDS FOR THE DOCUMENTATION OF A PATIENT'S WEIGHT, A FIELD TO DOCUMENT IN POUNDS AND A FIELD TO DOCUMENT WEIGHT IN KILOGRAMS. THE CLINICIAN MUST DOCUMENT IN THE FIELD THAT CORRESPONDS TO THE UNITS IN WHICH THE WEIGHT WAS MEASURED. THE NEAR MISSES REPORTED WERE RELATED TO A CLINICIAN DOCUMENTING INACCURATE INFORMATION INTO A CLEARLY LABELED TEMPLATE FIELD WITHIN ED PULSECHECK. PICIS CLINICAL SOLUTIONS, INC. IS PLANNING TO RELEASE THE NEXT VERSION OF THE ED PULSECHECK PRODUCT IN THE FOURTH QUARTER OF 2015. THIS VERSION OF ED PULSECHECK (V5.6) WILL INCLUDE AN ENHANCEMENT OPTION TO ONLY DISPLAY THE KG FIELD FOR WEIGHT DATA ENTRY. THIS ENHANCEMENT MAY MINIMIZE THE RISK OF A DATA ENTRY ERROR, ALTHOUGH THE ENHANCEMENT DOES NOT PREVENT THE RISK OF DATA ENTRY ERROR. THE ED PULSECHECK PRODUCT DID NOT CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT AND DID NOT MALFUNCTION. THE ED PULSECHECK PRODUCT OPERATED AS INTENDED, HOWEVER BASED UPON THE FDA'S MDR GUIDANCE RELATED TO USER ERROR PICIS CLINICAL SOLUTIONS, INC. IS SUBMITTING THIS MEDICAL DEVICE REPORT TO THE FDA.